DERMABOND UNKNOWN PRODUCT

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HTTPS://DOI.ORG/10.14744/EJMO.2021.12232. RELATED EVENTS CAPTURED VIA 2210968-2024-00673, 2210968-2024-00674.

Description of Event or Problem

TITLE: ADHESIVE GLUE VS SUBCUTICULAR SUTURES FOR CESAREAN SECTION SKIN CLOSURE: A DOUBLE BLIND RANDOMIZED CONTROLLED TRIAL. THE AIM OF THE STUDY WAS TO COMPARE THE WOUND COMPLICATION RATE, POSTOPERATIVE PAIN AND OVERALL PATIENT SATISFACTION BETWEEN ADHESIVE GLUE AND SUBCUTICULAR SUTURE IN WOMEN UNDERGOING ELECTIVE CAESAREAN SECTION (CS). THE STUDY CONDUCTED FROM (B)(6) 2020, WAS A PROSPECTIVE INTERVENTIONAL, DOUBLE BLINDED RANDOMIZED CONTROLLED, SINGLE CENTERED TRIAL. 120 WOMEN WHO FULFILLED THE CRITERIA WERE RANDOMIZED INTO TWO GROUPS. ONE GROUP TO RECEIVE ADHESIVE GLUE AND OTHER SUBCUTICULAR SUTURE FOR CLOSURE OF THEIR CS WOUND. IN BOTH GROUPS AFTER CLOSURE OF THE RECTUS FASCIA, THE SUBCUTANEOUS FAT LAYER WAS CLOSED WITH 3-4 INTERRUPTED UNSPECIFIED BRAND OF 1-0 CATGUT SUTURES. A DERMABOND WAS USED FOR EACH PATIENT FOR ADHESIVE GROUP WHILE IN THE SUTURE GROUP, THE SKIN WAS CLOSED WITH POLYGLACTIN 3-0 SUTURE UNDER THE SKIN USING A CONTINUOUS SUTURE. REPORTED COMPLICATION: SURGICAL SITE INFECTION (N-?). HEMATOMA (N-?). WOUND DISRUPTION (N-?). CONCLUSION: ADHESIVE GLUE MAY BE A USEFUL OPTION FOR SKIN CLOSURE OF PFANNENSTIEL SKIN INCISIONS AFTER CAESAREAN DELIVERY. IT HAS THE ADVANTAGES LIKE SHORTER SKIN CLOSURE AND OPERATING TIME, LESS POSTOPERATIVE PAIN AND SIMILAR COSMESIS AND SATISFACTION AMONG SURGEONS WITH NO INCREASES IN WOUND COMPLICATION RATES.